Drug intelligence / Profile preview

bifidobacterium infantis 35624

Development stage
Phase 3
Lead developer
Procter & Gamble
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Oral
01

Overview

Bifidobacterium infantis 35624 is a well-characterized probiotic bacterial strain originally isolated from the healthy human gut and widely studied for its effects on digestive health, particularly irritable bowel syndrome (IBS). Genomic sequencing has led to its reclassification as *Bifidobacterium longum* subsp. *longum* 35634, but it remains best known and marketed as *Bifidobacterium infantis* or *Bifantis*. This live biotherapeutic product is administered orally and has demonstrated safety and survivability through the gastrointestinal tract, reaching the gut alive[1][5]. Clinical studies have shown that supplementation with this strain can reduce symptoms of IBS such as abdominal pain/discomfort, bloating/distention, and difficulty passing stool[1][8][9]. The mechanism of action includes modulation of immune responses—specifically normalizing cytokine profiles such as IL-10/IL-12—and supporting a balanced gut microbiome[1][5]. It is included in international clinical guidelines for IBS management due to its evidence base[5].

Brand names
BifantisAlignPrecisionBiotics
Other names
bifidobacterium longum subsp. longum 35634

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